Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome

Phase 2 Completed 120 enrolled Michael A. Matthay Harborview Injury Prevention and Research Center · collab Oregon Health and Science University · collab The University of Texas Health Science Center, Houston · collab United States Department of Defense · collab University of Minnesota · collab Vanderbilt University Medical Center · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). This study is the extension of the Phase 1 pilot study (NCT01775774) and Phase 2a study (NCT02097641).

Timeline

Start: 2019-11-26
Primary completion: 2024-03-30
Completion: 2024-06-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Human Mesenchymal Stromal Cells vs Cell Reconstitution Media; p = 0.34 NCT03818854 ↗

paper There were no differences in the primary endpoint of change in oxygenation index from baseline during the 36 hours after study product administration PMID 40728562 ↗

Publications

Matthay MA, Zhuo H, Sarma A, Alipanah-Lechner N, Hendrickson C, Kornblith LZ, Schreiber M, Zonies D, Khan A, Robinson B, Johnson NJ, Ware LB, Guillamondegui O, Casey J, Moore L, Patel B, Kao L, Wade CE, Fox E, Cox C, Khawanja F, Aguillon Prada R, Hossri S, Callcut R, Albertson T, Delucchi KL, McMillan M, Langelier CR, Pati S, McKenna DH, Leroux C, Calfee CS, Liu KD. Treatment with Allogeneic Mesenchymal Stromal Cells for Moderate to Severe Acute Respiratory Distress Syndrome: A Double-Blind, Placebo-controlled, Multicenter Phase 2b Clinical Trial (STAT). Am J Respir Crit Care Med. 2026 Feb 1;212(3):428-439. doi: 10.1164/rccm.202411-2254OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Human Mesenchymal Stromal Cells	Cell therapy	1e+07 cells/kg	Intravenous